R260

R260
SPL v1
SPL
SPL Set ID 0e0770d8-680a-471a-b496-7105631ca6f4
Route
ORAL
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bellis Perennis Whole (2 [hp_X]) Calendula Officinalis Flowering Top (3 [hp_X]) Echinacea Angustifolia Whole (4 [hp_X]) Hamamelis Virginiana Root Bark/stem Bark (5 [hp_X]) Aconitum Napellus Whole (6 [hp_X]) Arnica Montana Whole (12 [hp_X]) Artemisia Annua Flowering Top Hypericum Perforatum Whole Achillea Millefolium Whole Amaryllis Belladonna Whole Calcium Sulfide Comfrey Root Activated Charcoal Mercurius Solubilis
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1984-08-15

Description

Bellis perennis 2X Calendula officinalis 2X Echinacea angustifolia 2X Hamamelis virginiana 2X Aconitum napellus 3X Arnica montana 3X Chamomilla 3X Hypericum perforatum 3X Millefolium 3X Belladonna 4X Hepar sulphuris calcareum 5X Symphytum officinale 6X Carbo vegetabilis 12X Mercurius solubilis 12X


Medication Information

Description

Bellis perennis 2X Calendula officinalis 2X Echinacea angustifolia 2X Hamamelis virginiana 2X Aconitum napellus 3X Arnica montana 3X Chamomilla 3X Hypericum perforatum 3X Millefolium 3X Belladonna 4X Hepar sulphuris calcareum 5X Symphytum officinale 6X Carbo vegetabilis 12X Mercurius solubilis 12X

Label

Est 1985

Professional Formulas

Complementary Health

Calendula Combination

Homeopathic Remedy

1 FL. OZ. (29.5 mL)

Section 50565-1

Keep out of the reach of children.

Section 53414-9

If pregnant or breastfeeding, ask a healthcare professional before use.

Section 55105-1

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings

If symptoms do not improve or are accompanied by a fever, consult a doctor. Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center right away. If pregnant or breastfeeding, ask a healthcare professional before use.

Questions

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

Directions

Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age.

Indications

For the temporary relief of mild pain, bruising, or swelling associated with minor injuries or wounds.*

Other Information

Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.

Active Ingredients

Bellis perennis 2X

Calendula officinalis 2X

Echinacea angustifolia 2X

Hamamelis virginiana 2X

Aconitum napellus 3X

Arnica montana 3X

Chamomilla 3X

Hypericum perforatum 3X

Millefolium 3X

Belladonna 4X

Hepar sulphuris calcareum 5X

Symphytum officinale 6X

Carbo vegetabilis 12X

Mercurius solubilis 12X

Inactive Ingredients

40% ethanol, purified water.


Structured Label Content

Label (LABEL)

Est 1985

Professional Formulas

Complementary Health

Calendula Combination

Homeopathic Remedy

1 FL. OZ. (29.5 mL)

Section 50565-1 (50565-1)

Keep out of the reach of children.

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a healthcare professional before use.

Section 55105-1 (55105-1)

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings (WARNINGS)

If symptoms do not improve or are accompanied by a fever, consult a doctor. Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center right away. If pregnant or breastfeeding, ask a healthcare professional before use.

Questions (QUESTIONS)

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

Directions (DIRECTIONS)

Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age.

Indications (INDICATIONS)

For the temporary relief of mild pain, bruising, or swelling associated with minor injuries or wounds.*

Other Information (OTHER INFORMATION)

Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.

Active Ingredients (ACTIVE INGREDIENTS)

Bellis perennis 2X

Calendula officinalis 2X

Echinacea angustifolia 2X

Hamamelis virginiana 2X

Aconitum napellus 3X

Arnica montana 3X

Chamomilla 3X

Hypericum perforatum 3X

Millefolium 3X

Belladonna 4X

Hepar sulphuris calcareum 5X

Symphytum officinale 6X

Carbo vegetabilis 12X

Mercurius solubilis 12X

Inactive Ingredients (INACTIVE INGREDIENTS)

40% ethanol, purified water.


Advanced Ingredient Data


Raw Label Data

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